Specialist Quality Control

Specialist Quality Control

The Specialist Quality Control will support the QC analytical chemistry team by performing testing primarily supporting separation and mass spectrometric (LC/MS) testing in support of assessing the quality attributes of protein therapeutics across Amgen’s development portfolio. Under minimal supervision, this position will also support HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CEX (cation exchange), Capillary Electrophoresis (CE) and HILIC (hydrophilic interaction). Staff member may also perform additional activities such as owning Chane Control and Non-Conformance records; and additional testing support such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

Specific responsibilities include:

Familiarity/experience with cGMP expectations

Support method development and optimization in collaboration with Process Development colleagues

Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports

Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate execution of procedures and processes

Support introduction of new methods/techniques into the lab

Perform complex assay and instrument troubleshooting

Provide leadership and technical support to team members

Basic Qualifications:

Doctorate Degree

OR

Master’s Degree 2 years of operations or quality experience

OR

Bachelor’s Degree 4 years of operations or quality experience

OR

Associate’s degree 10 years of operations or quality experience

OR

High school diploma/GED 12 years of operations or quality experience

Preferred Qualifications:

Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics

Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics

Strong interpersonal skills, along with outstanding verbal and written communication and problem-solving skills are essential

Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

About this company

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses